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Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): protocol for a feasibility cluster-randomised controlled trial
- Source :
- Trials, Trials, Vol 21, Iss 1, Pp 1-12 (2020)
- Publication Year :
- 2020
- Publisher :
- BMC (part of Springer Nature), 2020.
-
Abstract
- Background Cognitive difficulties experienced by people with multiple sclerosis (MS) impact their quality of life and daily functioning, from childcare and work, to social and self-care activities. Despite the high prevalence of cognitive difficulties seen in MS, there is a lack of developed programmes that target cognition, while also supporting patients by helping them to function well in everyday life. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed as a holistic, individualised cognitive rehabilitation intervention. It addresses the wide-ranging symptoms and functional difficulties that present in MS, including the ability to maintain employment, social activities, home management and self-care. The aim of the current research is to evaluate the feasibility and preliminary efficacy of COB-MS for people with MS. The focus is on feasibility outcomes as well as functioning associated with cognitive difficulty and secondary outcomes related to cognition, fatigue and quality of life. Methods One hundred and twenty people with MS will be assigned to participate in either the COB-MS programme or a treatment as usual, wait-list control group as part of this single-blind, cluster-randomised controlled feasibility and preliminary efficacy trial of the COB-MS programme. The COB-MS group will participate in an eight-session occupational-based cognitive rehabilitation programme over 9 weeks. The primary outcome measure is the goal attainment scaling at 12 weeks. Participants will be assessed pre-intervention, post-intervention and at 12 weeks post-intervention and 6 months post-intervention. Qualitative evaluations of participants’ perspectives will also be examined as part of the feasibility study. Discussion Results will provide recommendations for a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy. In the event that results indicate efficacy, study findings will suggest that COB-MS requires consideration as a means of enhancing cognitive and daily functioning in people living with MS. Trial registration ISRCTN: ISRCTN11462710. Registered on 9 September 2019.
- Subjects :
- Occupational therapy
medicine.medical_specialty
Cost-Benefit Analysis
Medicine (miscellaneous)
Goal Attainment Scaling
Multiple sclerosis
Study Protocol
03 medical and health sciences
Cognition
0302 clinical medicine
Quality of life (healthcare)
Cognitive occupation-based programme
Intervention (counseling)
Activities of Daily Living
medicine
Protocol
Humans
Single-Blind Method
Pharmacology (medical)
030212 general & internal medicine
Cluster randomised controlled trial
Cognitive rehabilitation therapy
Everyday life
Randomized Controlled Trials as Topic
lcsh:R5-920
Cognitive Behavioral Therapy
business.industry
Feasibility
Cognitive rehabilitation
Self Care
Treatment Outcome
Quality of Life
Physical therapy
Feasibility Studies
lcsh:Medicine (General)
business
030217 neurology & neurosurgery
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Trials, Trials, Vol 21, Iss 1, Pp 1-12 (2020)
- Accession number :
- edsair.doi.dedup.....722292c16a93773b60615fd93bab871a